510(k) · Cleared
ClearedChina Nails and Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · JDS Nail, Fixation, Bone
Cleared on Mar 14, 2013 as substantially equivalent to K040212 (Smith & Nephew, Inc., 2004) and 2 other predicates after an 83-day review. Its family tree reaches back 5 generations to 1998.
- Decided
- Mar 14, 2013
- Review
- 83 days
- Class
- Class II
- Product code
- JDS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K981529 (1998). 18 ancestors in all, the oldest K951740 (1995). No later device cites it as a predicate yet.
- Root · 5 generations backK981529 Titanium Intramedullary Nail, Titanium Locking ScrewSmith & Nephew, Inc. · 1998 · Recalled
- 4 generations backK040212 Trigen IntertanSmith & Nephew, Inc. · 2004 · Recalled
- 3 generations backK040656 Modification to Smith & Nephew Intramedullary Hip ScrewSmith & Nephew, Inc. · 2004
- 2 generations backK050226 Asian Intramedullary Hip Screw NailsSmith & Nephew, Inc. · 2005
- 1 generation backK092748 Sureshot Tan Nails and AccessoriesSmith & Nephew, Inc. · 2010 · Recalled
- This deviceK123948 China Nails and AccessoriesSmith & Nephew, Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K981529 | Titanium Intramedullary Nail, Titanium Locking Screw | Smith & Nephew, Inc. | 1998 | 2 |
| −4 | K040212 | Trigen Intertan | Smith & Nephew, Inc. | 2004 | 6 |
| −3 | K040656 | Modification to Smith & Nephew Intramedullary Hip Screw | Smith & Nephew, Inc. | 2004 | — |
| −2 | K050226 | Asian Intramedullary Hip Screw Nails | Smith & Nephew, Inc. | 2005 | — |
| −1 | K092748 | Sureshot Tan Nails and Accessories | Smith & Nephew, Inc. | 2010 | 1 |
| 0 (this device) | K123948 | China Nails and Accessories | Smith & Nephew, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 3 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2011 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JDS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JDS device
- #1 K230761 TRIGEN META-NAIL Nail Systemscore 12.4 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K040212 | Trigen IntertanSummary page 1…e component metallic bone fixation appliances and accessories Device Class: 11 Panel Code: Orthopaedics/87 JOS Predicate Devices: Smith & Nephew TRIGEN InterTAN (K040212) Smith & Nephew SURESHOT TAN and Accessories (K092748) Smith & Nephew TRIGEN Low Profile Bone Screws (1111025) Device Description… | 2004 |
| * | K092748 | Sureshot Tan Nails and AccessoriesSummary page 1…nd accessories Device Class: 11 Panel Code: Orthopaedics/87 JOS Predicate Devices: Smith & Nephew TRIGEN InterTAN (K040212) Smith & Nephew SURESHOT TAN and Accessories (K092748) Smith & Nephew TRIGEN Low Profile Bone Screws (1111025) Device Description: Subject devices of this submission are China Nails a… | 2010 |
| * | K111025 | Trigen Low Profile Bone ScrewSummary page 1…87 JOS Predicate Devices: Smith & Nephew TRIGEN InterTAN (K040212) Smith & Nephew SURESHOT TAN and Accessories (K092748) Smith & Nephew TRIGEN Low Profile Bone Screws (1111025) Device Description: Subject devices of this submission are China Nails and Accessories. The implant components included in the s… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 1 company; a new generation was cleared every 2.9 years on median.
- 9 of the 18 ancestors have a recall of any class.
- 16 other devices also cite its predicate K040212.
How does its category compare?
All JDS devicesJDS Nail, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · JDS
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JDS
146in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JDS
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDS
497in 2025
MAUDE reports naming product code JDS, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 161 |
| 2008 | 1 | — | 0 | 169 |
| 2009 | 0 | — | 3 | 160 |
| 2010 | 0 | — | 2 | 70 |
| 2011 | 1 | — | 0 | 104 |
| 2012 | 0 | — | 0 | 195 |
| 2013 | 1 | — | 4 | 284 |
| 2014 | 0 | — | 0 | 388 |
| 2015 | 1 | — | 0 | 316 |
| 2016 | 0 | — | 0 | 506 |
| 2017 | 0 | — | 1 | 287 |
| 2018 | 0 | — | 0 | 320 |
| 2019 | 0 | — | 0 | 490 |
| 2020 | 3 | 106 | 1 | 643 |
| 2021 | 0 | — | 0 | 630 |
| 2022 | 0 | — | 0 | 589 |
| 2023 | 1 | — | 0 | 357 |
| 2024 | 3 | 146 | 0 | 466 |
| 2025 | 1 | — | 2 | 497 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The China Nails are indicated for simple long bone fractures; severely comminuted,
spiral, long oblique and segmental fractures; nonunions and malunions; polytrauma and
multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction,
following tumor resection and grafting; bone lengthening and shortening; subtrochanteric
fractures; ipsilateral femoral shaft/neck fractures; intertrochanteric fractures; and
intracapsular fractures. The Smith & Nephew, Inc. China Nail is for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123948 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123948: China Nails and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123948
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026